UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050064 |
|---|---|
| Receipt number | R000057035 |
| Scientific Title | Smartphone-Based Cognitive Behavioral Therapy for Subthreshold Social Anxiety in Adolescences: A Multi-center Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/01/27 |
| Last modified on | 2025/04/01 18:24:44 |
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Basic information
Public title
Smartphone cognitive behavioral therapy for social anxiety in adolescences
Acronym
A Clinical Trial of Smartphone-App based Cognitive Behavioral Therapy among Adolescences with Social Anxiety
Scientific Title
Smartphone-Based Cognitive Behavioral Therapy for Subthreshold Social Anxiety in Adolescences: A Multi-center Randomized Controlled Trial
Scientific Title:Acronym
Smartphone-Based Cognitive Behavioral Therapy for Subthreshold Social Anxiety in Adolescences: Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Subthreshold Social Anxiety
Classification by specialty
| Psychiatry | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to examine effectiveness of web-based CBT for sub-threshold social anxiety in adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Mean differences in the total Leibovitz Social Anxiety Scale from baseline to post-intervention (10 weeks after intervention start).
Key secondary outcomes
The secondary outcomes are changes in scales for measuring clinical symptoms and quality of life (QOL): Liebowitz Social Anxiety Scale, LSAS; Social Phobia Inventory, SPIN; Patient Health Quesitonnire-9, PHQ-9; Generalized Anxiety Disorder Quesitonnire-7, GAD-7; EuroQol 5 Dimensions 5-Level, EQ-5D-5L.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Smartphone-App education baed on cognitive behavioral therapy
Interventions/Control_2
No tretment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who meet all of the following criteria
Have sub-threshold social anxiety (LSAS total score > 30 points).
User of his/her smartphone on a daily basis.
15 to 25 years old.
Adolecenses and young adults enrolled high school, university, vocational school, etc.
Key exclusion criteria
Meet diagnostic criteria for social anxiety disorder on DSM-5.
Conducted cognitive-behavioral therapy for social anxiety within 2 years.
IQ < 85.
Mental disorders such as major depressive disorder.
High risk of suicide.
Progressive disease such as cancer.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakamura |
Organization
Kagoshima University Hospital
Division name
Department of Psychiatry
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL
099-275-5707
nakamu36@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Kagoshima University Hospital
Division name
Division of Clinical Psychology
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL
099-275-5707
Homepage URL
k2782199@kadai.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Fukui, Chiba University, Naruto University of Education, Shigakukan University, Fukusima Gakuin University, Jinai University, Kochi Kokusai High School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
Tel
099-275-5111
crmc@m2.kufm.kagoshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福井大学（福井県）、千葉大学（千葉県）、鳴門教育大学（徳島県）、志學館大学（鹿児島県）、福島学院大学（福島県）、仁愛大学（福井県）、高知国際高等学校（高知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
https://pediatrics.jmir.org/2024/1/e55786/
Publication of results
Published
Result
URL related to results and publications
https://pediatrics.jmir.org/2024/1/e55786/
Number of participants that the trial has enrolled
77
Results
Results from the analysis of covariance with depression as covariates showed that the participants in the intervention group had significantly reduced symptoms of social anxiety, depression, and general anxiety compared to the control group.
Results date posted
| 2025 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 22 | Day |
Baseline Characteristics
Representative participants were Japanese university students around the age of 21 who exhibited moderate social anxiety. Females comprised 66% of the sample, and there were no significant differences in epidemiological and clinical features between the intervention and control groups.
Participant flow
After eligibility screening, 89 students were deemed eligible, and 77 proceeded to study enrollment. Based on a pre-specified randomization sequence, participants were randomly assigned, yielding 38 participants in the intervention group and 39 in the control group. By the time of follow-up, five participants from the intervention group and two from the control group could not be contacted and withdrew from the research.
Adverse events
No adverse event.
Outcome measures
LSAS-j, SPIN, PHQ-9, GAD-7, and EQ-5D-5L.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057035
